JP6516829B2 - 第viii因子製剤 - Google Patents

第viii因子製剤 Download PDF

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JP6516829B2
JP6516829B2 JP2017506297A JP2017506297A JP6516829B2 JP 6516829 B2 JP6516829 B2 JP 6516829B2 JP 2017506297 A JP2017506297 A JP 2017506297A JP 2017506297 A JP2017506297 A JP 2017506297A JP 6516829 B2 JP6516829 B2 JP 6516829B2
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aqueous composition
fviii
concentration
composition according
composition
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JP2017528440A (ja
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ウーヴェ・リービンク
フーベルト・メツナー
クリスティーナ・ボーデンベンダー
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シーエスエル、リミテッド
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00Medicinal preparations containing peptides
    • A61K38/16Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/17Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/36Blood coagulation or fibrinolysis factors
    • A61K38/37Factors VIII
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/02Inorganic compounds
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/16Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
    • A61K47/18Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/16Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
    • A61K47/18Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
    • A61K47/183Amino acids, e.g. glycine, EDTA or aspartame
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/20Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing sulfur, e.g. dimethyl sulfoxide [DMSO], docusate, sodium lauryl sulfate or aminosulfonic acids
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/22Heterocyclic compounds, e.g. ascorbic acid, tocopherol or pyrrolidones
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/26Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0019Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0087Galenical forms not covered by A61K9/02 - A61K9/7023
    • A61K9/0095Drinks; Beverages; Syrups; Compositions for reconstitution thereof, e.g. powders or tablets to be dispersed in a glass of water; Veterinary drenches
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/08Solutions
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/19Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles lyophilised, i.e. freeze-dried, solutions or dispersions
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P7/00Drugs for disorders of the blood or the extracellular fluid
    • A61P7/04Antihaemorrhagics; Procoagulants; Haemostatic agents; Antifibrinolytic agents
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K14/00Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • C07K14/435Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • C07K14/745Blood coagulation or fibrinolysis factors
    • C07K14/755Factors VIII, e.g. factor VIII C (AHF), factor VIII Ag (VWF)

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Hematology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Zoology (AREA)
  • Biochemistry (AREA)
  • Molecular Biology (AREA)
  • Immunology (AREA)
  • Organic Chemistry (AREA)
  • Inorganic Chemistry (AREA)
  • Dermatology (AREA)
  • Toxicology (AREA)
  • Diabetes (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Genetics & Genomics (AREA)
  • Biophysics (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Medicinal Preparation (AREA)
  • Peptides Or Proteins (AREA)
JP2017506297A 2014-08-04 2015-07-24 第viii因子製剤 Active JP6516829B2 (ja)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
EP14179732 2014-08-04
EP14179732.4 2014-08-04
PCT/EP2015/066999 WO2016020210A1 (en) 2014-08-04 2015-07-24 Csl behring gmbh

Publications (2)

Publication Number Publication Date
JP2017528440A JP2017528440A (ja) 2017-09-28
JP6516829B2 true JP6516829B2 (ja) 2019-05-22

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JP2017506297A Active JP6516829B2 (ja) 2014-08-04 2015-07-24 第viii因子製剤

Country Status (17)

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US (1) US10238718B2 (es)
EP (1) EP3177317B1 (es)
JP (1) JP6516829B2 (es)
KR (1) KR102192494B1 (es)
CN (1) CN106687126B (es)
AU (1) AU2015299224B2 (es)
BR (1) BR112017002090B1 (es)
CA (1) CA2956412A1 (es)
DK (1) DK3177317T3 (es)
ES (1) ES2788870T3 (es)
IL (1) IL250343B (es)
MX (1) MX2017000862A (es)
NZ (1) NZ729629A (es)
PL (1) PL3177317T3 (es)
RU (1) RU2689338C2 (es)
SG (2) SG11201700550YA (es)
WO (1) WO2016020210A1 (es)

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CN106279437B (zh) * 2016-08-19 2017-10-31 安源医药科技(上海)有限公司 高糖基化人凝血因子viii融合蛋白及其制备方法与用途
US11142553B2 (en) 2016-11-29 2021-10-12 Spiber Inc. Protein composition, method for producing same and method for improving heat stability
WO2018132874A1 (en) * 2017-01-19 2018-07-26 Csl Limited Method of preventing an immune response with alpha- 1 anti-trypsin
WO2019094521A1 (en) 2017-11-07 2019-05-16 Rani Therapeutics, Llc Clotting factor preparations for delivery into tissue of the intestinal tract using a swallowable drug delivery device
CN110950964B (zh) * 2018-09-26 2021-06-18 安源医药科技(上海)有限公司 突变型单链人凝血因子viii融合蛋白及其制备方法与用途
CN112138149A (zh) * 2019-06-28 2020-12-29 北京基科晟斯医药科技有限公司 重组凝血因子viii制剂
US20220380439A1 (en) 2020-11-09 2022-12-01 Takeda Pharmaceutical Company Limited Purification of fviii from plasma using silicon oxide adsorption

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US4877608A (en) 1987-11-09 1989-10-31 Rorer Pharmaceutical Corporation Pharmaceutical plasma protein formulations in low ionic strength media
DE69029765T2 (de) 1989-07-24 1997-05-15 Bayer Ag Stabilisierung von hochgereinigten Proteinen
DE4001451A1 (de) 1990-01-19 1991-08-01 Octapharma Ag Stabile injizierbare loesungen von faktor viii und faktor ix
DE4111393A1 (de) 1991-04-09 1992-10-15 Behringwerke Ag Stabilisierte faktor viii-praeparationen
AU670793B2 (en) 1992-04-30 1996-08-01 Alpha Therapeutic Corporation Improved solubilization and stabilization of factor VIII complex
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GB9501040D0 (en) 1995-01-19 1995-03-08 Quadrant Holdings Cambridge Dried composition
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Publication number Publication date
KR102192494B1 (ko) 2020-12-18
JP2017528440A (ja) 2017-09-28
AU2015299224A1 (en) 2017-03-23
CN106687126A (zh) 2017-05-17
MX2017000862A (es) 2017-05-01
DK3177317T3 (en) 2020-06-15
EP3177317A1 (en) 2017-06-14
WO2016020210A1 (en) 2016-02-11
EP3177317B1 (en) 2020-03-18
SG10201900598TA (en) 2019-02-27
SG11201700550YA (en) 2017-02-27
CN106687126B (zh) 2020-07-28
AU2015299224B2 (en) 2019-06-20
BR112017002090B1 (pt) 2021-06-01
PL3177317T3 (pl) 2020-07-27
KR20170040327A (ko) 2017-04-12
RU2017106159A (ru) 2018-09-06
WO2016020210A8 (en) 2016-04-28
BR112017002090A2 (pt) 2018-01-30
RU2017106159A3 (es) 2018-11-28
IL250343B (en) 2020-10-29
IL250343A0 (en) 2017-03-30
RU2689338C2 (ru) 2019-05-27
CA2956412A1 (en) 2016-02-11
US10238718B2 (en) 2019-03-26
NZ729629A (en) 2021-12-24
ES2788870T3 (es) 2020-10-23
US20170252412A1 (en) 2017-09-07

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